Most of you have probably heard the news about the nine patients that died after being treated with parenteral nutrition solution suspected of being contaminated with the bacterium, Serratia marcescens, at six Alabama hospitals.
Reuters has reported that the family of at least one patient, Mary Ellen Kise, is suing the IV manufacturer, Meds IV LLC. The manufacturer recalled the product shortly after the deaths were confirmed.
A Birmingham law firm, Hare Wynn Newell and Newton, is currently working with the families of two other patients and a Shelby County, Ala., judge has ordered Meds IV LLC not to destroy evidence related to the recall, according to news reports. I’d like to take the opportunity to discuss some of the potential legal ramifications in this blog.
Let’s review the facts. Each of the patients that died developed Serratia marcescens bacteremia; an additional 10 patients were sickened from the bacteria. The Alabama State Health Department and the CDC are currently investigating conditions at the two hospitals where the deaths took place and a third hospital where other cases of bacteremia were reported. A total of seven Alabama hospitals administered the parenteral nutrition solution.
Although I am not an attorney and cannot predict where the strengths of this case will lie, I can offer a legal nurse perspective as to what records are will be important.
It appears that the plaintiff has a very strong, clear case here: patients died after they were administered a specific parenteral solution. Using medical records, a legal team will be able to corroborate risk factors and determine whether infection control measures were implemented.
Although the case will likely focus on showing liability on the behalf of the pharmaceutical company that produced the solution, the legal and ethical responsibilities of the hospital and pharmacy that distributed the solution may also come under question.
Another important aspect to determine will be the source of contamination. The following records will be especially important for legal nurse consultants and attorneys who are working on this case:
- Autopsy reports, if available.
- Patient history of present illness at the time of death including all laboratory and microbiology reports. Specific attention should be paid to the time that elapsed between admission, exposure, post-exposure and/or death.
- Cultures of the tainted parenteral solution.
- State and CDC investigative reports, if available.
- Research on S. marcescens and other related cases involving this bacterium that may be similar.
At first glance this case seems very straightforward from the plaintiff’s standpoint, but there are also certain aspects that the defense can argue. The following points may help them establish their side of this case:
- Records of hospital pharmacy policy and procedures.
- Hospital infection control policy and procedures.
- Determining whether the bacteria entered the parenteral solution as a result of tampering by the hospital staff, or if the bacteria originated from the pharmaceutical company. A quick literature search on my part revealed that a previous case of S. marcescens bacteremia in a hospital was traced to a narcotic infusion, as published in the New England Journal of Medicine.
- Determining whether the deaths resulted directly from the bacteremia or from other medical conditions.
Paying attention to high profile medicolegal cases like this in the news can will help you understand both sides of a lawsuit and will help make you a stronger LNC.